Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT05017194
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2021-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014257', 'term': 'Trichuriasis'}, {'id': 'D006725', 'term': 'Hookworm Infections'}, {'id': 'D000724', 'term': 'Ancylostomiasis'}], 'ancestors': [{'id': 'D017189', 'term': 'Enoplida Infections'}, {'id': 'D017188', 'term': 'Adenophorea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017206', 'term': 'Strongylida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C468987', 'term': 'emodepside'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 442}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-26', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cure rate (CR) of emodepside against Trichuris trichiura', 'timeFrame': 'In the week between 14 and 21 days post-treatment', 'description': 'CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.'}, {'measure': 'Cure rate (CR) of emodepside against hookworm', 'timeFrame': 'In the week between 14 and 21 days post-treatment', 'description': 'CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Egg Reduction Rate (ERR) of the emodepside against Trichuris trichiura and hookworm.', 'timeFrame': 'In the week between 14 and 21 days post-treatment', 'description': 'Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\\*100).'}, {'measure': 'CR against Ascaris lumbricoides', 'timeFrame': 'In the week between 14 and 21 days post-treatment', 'description': 'CR will be calculated as the percentage of Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.'}, {'measure': 'ERR against Ascaris lumbricoides', 'timeFrame': 'In the week between 14 and 21 days post-treatment', 'description': 'Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\\*100).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emodepside', 'Trichuris trichiura', 'Hookworm', 'Soil-transmitted helminths', 'Efficacy', 'Safety', 'Dose selection'], 'conditions': ['Trichuris Trichiura; Infection', 'Hookworm Infections']}, 'referencesModule': {'references': [{'pmid': '37195949', 'type': 'DERIVED', 'citation': 'Montresor A, Gabrielli AF. Emodepside - A Promising Drug for the Treatment of Soil-Transmitted Helminthiases. N Engl J Med. 2023 May 18;388(20):1907-1908. doi: 10.1056/NEJMe2303793. No abstract available.'}, {'pmid': '37195942', 'type': 'DERIVED', 'citation': 'Mrimi EC, Welsche S, Ali SM, Hattendorf J, Keiser J. Emodepside for Trichuris trichiura and Hookworm Infection. N Engl J Med. 2023 May 18;388(20):1863-1875. doi: 10.1056/NEJMoa2212825.'}]}, 'descriptionModule': {'briefSummary': 'The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adults aged between 18 and 45 years\n* Written and signed informed consent\n* Examined by a study physician before treatment\n* Provided two stool samples at baseline\n* Trichuris trichiura and hookworm EPG ≥ 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and hookworm eggs\n\nExclusion Criteria:\n\n* Pregnant or lactating and/or planning to become pregnant within three months after drug treatment\n* Type 1 and/or 2 diabetes\n* Psychiatric disorders\n* History of ophthalmological conditions\n* Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment\n* Suffers from severe anaemia (Hb \\< 80 g/l)\n* Received anthelminthic treatment within past four weeks\n* Attending other clinical trials during the study\n* Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin\n* Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir'}, 'identificationModule': {'nctId': 'NCT05017194', 'acronym': 'EMODEP_PEMBA', 'briefTitle': 'Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Tropical & Public Health Institute'}, 'officialTitle': 'Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials', 'orgStudyIdInfo': {'id': 'EMODEP_PEMBA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emodepside 5 mg', 'interventionNames': ['Drug: Emodepside']}, {'type': 'EXPERIMENTAL', 'label': 'Emodepside 10 mg', 'interventionNames': ['Drug: Emodepside']}, {'type': 'EXPERIMENTAL', 'label': 'Emodepside 15 mg', 'interventionNames': ['Drug: Emodepside']}, {'type': 'EXPERIMENTAL', 'label': 'Emodepside 20 mg', 'interventionNames': ['Drug: Emodepside']}, {'type': 'EXPERIMENTAL', 'label': 'Emodepside 25 mg', 'interventionNames': ['Drug: Emodepside']}, {'type': 'EXPERIMENTAL', 'label': 'Emodepside 30 mg', 'interventionNames': ['Drug: Emodepside']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Albendazole', 'interventionNames': ['Drug: Emodepside']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Emodepside']}], 'interventions': [{'name': 'Emodepside', 'type': 'DRUG', 'description': 'Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.', 'armGroupLabels': ['Albendazole', 'Emodepside 10 mg', 'Emodepside 15 mg', 'Emodepside 20 mg', 'Emodepside 25 mg', 'Emodepside 30 mg', 'Emodepside 5 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '122', 'city': 'Chake Chake', 'country': 'Tanzania', 'facility': 'Public Health Laboratory - Ivo de Carneri', 'geoPoint': {'lat': -5.24586, 'lon': 39.76659}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jennifer Keiser', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Laboratory Ivo de Carneri', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Jennifer Keiser', 'investigatorAffiliation': 'Swiss Tropical & Public Health Institute'}}}}